- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04121559
A Feasibility Study of Delivering Adolescent Nutrition Interventions Through School-Based Platforms in Ethiopia
A Feasibility Study of Delivering Adolescent Nutrition Interventions Through School-Based Platforms in Ethiopia: A Cluster-Randomized Evaluation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Adolescence is a critical period of physical and psychological development and for achieving human potential. Rapid physical, psychosocial and cognitive growth and development is coupled with increased energy and nutrient requirements (Das et al., 2017; Spear 2002). Poor nutrition during adolescence can have adverse consequences impacting health in adulthood. The significance of nutrition during adolescence is especially important for girls, as poor nutrition can affect their well-being as well as the survival, health and well-being of their children (Das et al. 2017).
A&T Ethiopia implemented a package of adolescent nutrition interventions through school-based (flag assemblies, classroom lessons, girls' clubs, peer mentoring, weight and height measurement, and parent-teacher meetings) and community platforms (health post and home visits and community gatherings). IFPRI tested the feasibility of the behavior-change interventions and examined their impacts on adolescent girls' diets, compared with standard school and community activities in control areas.
The evaluation used a two-arm cluster-randomized, non-masked trial design, consisting of two cross-sectional surveys of in-school adolescent girls aged 10-14 years enrolled in grades 4-8. The unit of randomization is the primary school which includes grades 1-8. The baseline survey was conducted in October-November 2019 (at the beginning of the school year), and the endline survey took place in March-April 2021 (following the end of first semester classes). In 2020, after 3 months of program implementation, program activities were halted from March to October (over 6 months) due to the COVID-19 pandemic, thus the endline survey was postponed to the following school year after implementation was reinitiated.
The overall study objective was to determine the feasibility of delivering adolescent nutrition interventions primarily through school-based platforms and their impact on the diet of adolescent girls.
Research questions include:
- What is the program impact on the diet of adolescent girls: (1) dietary diversity, (2) meal frequency, and (3) less consumption of unhealthy foods/junk foods?
- What is the exposure to adolescent nutrition interventions delivered through school-based platforms?
- What factors influenced the integration of adolescent nutrition interventions into school-based platforms and their outcomes?
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
District of Columbia
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Washington, District of Columbia, United States, 20005
- International Food Policy Research Institute
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Currently enrolled in primary school grades 4-8
- Parental consent and informed assent received
- Principals, teachers, service providers and primary schools in the areas
Exclusion Criteria:
- Age <10 years or >14 years
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
A&T intervention areas: adolescent-nutrition-focused behavior change interventions delivered through government primary schools and communities
|
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No Intervention: Control
Comparison areas: standard activities at government primary schools
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dietary diversity among adolescent girls
Time Frame: Approximately 17 months after baseline in a cross-sectional endline survey in March-April 2021
|
Mean number of food groups consumed by adolescent girls on the day preceding the interview.
|
Approximately 17 months after baseline in a cross-sectional endline survey in March-April 2021
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Minimum dietary diversity among adolescent girls
Time Frame: Approximately 17 months after baseline in a cross-sectional endline survey in March-April 2021
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Proportion of adolescent girls who consumed 5 or more food groups on the day preceding the interview.
|
Approximately 17 months after baseline in a cross-sectional endline survey in March-April 2021
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Meal frequency
Time Frame: Approximately 17 months after baseline in a cross-sectional endline survey in March-April 2021
|
Number of meal/snack times in the previous 24 hours
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Approximately 17 months after baseline in a cross-sectional endline survey in March-April 2021
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Consumption of unhealthy foods
Time Frame: Approximately 17 months after baseline in a cross-sectional endline survey in March-April 2021
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Consumption of sweets, baked sweets, sweetened beverages, and fried and salty foods in the previous 24 hours
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Approximately 17 months after baseline in a cross-sectional endline survey in March-April 2021
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Exposure to nutrition interventions at school and in the community
Time Frame: Approximately 17 months after baseline in a cross-sectional endline survey in March-April 2021
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Proportion of adolescent girls exposed to nutrition interventions at school and in the community
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Approximately 17 months after baseline in a cross-sectional endline survey in March-April 2021
|
Nutrition and handwashing knowledge and practices among adolescent girls and their parents
Time Frame: Approximately 17 months after baseline in a cross-sectional endline survey in March-April 2021
|
Proportion of adolescent girls and parents with correct knowledge of nutrition and appropriate handwashing practices based on survey responses
|
Approximately 17 months after baseline in a cross-sectional endline survey in March-April 2021
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Nutrition and handwashing knowledge among school science teachers, principals, and HEWs
Time Frame: Approximately 17 months after baseline in a cross-sectional endline survey in March-April 2021
|
Proportion of school science teachers, principals, and HEWs with correct knowledge of nutrition and appropriate handwashing practices based on survey responses
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Approximately 17 months after baseline in a cross-sectional endline survey in March-April 2021
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Delivery of adolescent nutrition interventions by school science teachers, principals, and HEWs
Time Frame: Approximately 17 months after baseline in a cross-sectional endline survey in March-April 2021
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Proportion of school science teachers, principals, and HEWs providing adolescent nutrition interventions at school and in the community based on survey responses
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Approximately 17 months after baseline in a cross-sectional endline survey in March-April 2021
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Availability of supporting resources
Time Frame: Approximately 17 months after baseline in a cross-sectional endline survey in March-April 2021
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Proportion of primary schools with training and supportive supervision for teachers/staff, educational materials, and healthy food environments based on enumerator observation and survey responses
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Approximately 17 months after baseline in a cross-sectional endline survey in March-April 2021
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Collaborators and Investigators
Publications and helpful links
General Publications
- Das JK, Salam RA, Thornburg KL, Prentice AM, Campisi S, Lassi ZS, Koletzko B, Bhutta ZA. Nutrition in adolescents: physiology, metabolism, and nutritional needs. Ann N Y Acad Sci. 2017 Apr;1393(1):21-33. doi: 10.1111/nyas.13330.
- Spear BA. Adolescent growth and development. J Am Diet Assoc. 2002 Mar;102(3 Suppl):S23-9. doi: 10.1016/s0002-8223(02)90418-9. No abstract available.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PHND-19-0949
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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